What Is the Hilfsmittelverzeichnis – and Why Does Listing Matter?
The German Medical Technical Aids Register (Hilfsmittelverzeichnis – HMV) maintains the German Medical Technical Aids-Register under § 139 SGB V (German Social Code Book V). It lists medical aids (for use in the home environment) that fall under the benefit obligation of statutory health insurance. The directory is structured into product groups, which are further broken down by area of application, product subgroup, and product type. For your product to be listed under a specific product type, it must match the definition of the overarching product group, fit the description of that product type, and be intended for the indications specified there. For your product to be listed under a specific product type, it must match the definition of the overarching product group, fit the description of that product type, and be intended for the indications specified there.
Each Product group comes with its own definitions and guidance on statutory benefit entitlements. Where ensuring sufficient, appropriate and cost-effective care requires it, additional indication- or use-related requirements apply. These requirements are regularly revised as part of ongoing updates (HMV-Updates). That's exactly why a careful pre-check against the currently valid version of your product group pays off before you assemble your documents.
For manufacturer , a listing means one thing above all: predictable reimbursability. Insured patients receive your product as part of their medical treatment without payers questioning reimbursement on a case-by-case basis. That makes listing a central lever for market access in Germany.
The Requirements Your Product Must Meet
The SGB V, § 139 para. 4, sets out the requirements for listing. As a manufacturer, you must demonstrate
- that your product is functionally suitable and safe,
- that it meets the quality requirements set out in the Hilfsmittelverzeichnis,
- that – where required – a medical benefit has been demonstrated, and
- that all information (such as the instructions for use) is available in German.
On top of that: the Hilfsmittelverzeichnis only lists series-produced products, not prototypes. Your product must also clearly fit an existing product type – or you need to justify, as part of the application, why a new product type is required. For novel products without an established comparator, the GKV-Spitzenverband typically requires a standalone demonstration of medical benefit based on the current, generally recognised state of medical knowledge.
Since most medical aids are also medical devices under the MDR (Regulation (EU) 2017/745) , the demonstration of functional suitability and safety is generally considered fulfilled through CE marking. The German Medical Technical Aids Register (Hilfsmittelverzeichnis – HMV) checks the formal validity of the CE marking on your declaration of conformity and, where applicable, the certificates of the involved notified body. Important: if the submitted certificate is time-limited, its remaining validity is checked as well. If you're still working with an expiring MDD certificate from the transition period, clarify this before submitting your HMV application.
Is Your Product Even a Case for the HMV?
Not every product belongs in the Hilfsmittelverzeichnis. Pure software applications without a hardware component follow a separate route in Germany: the directory of reimbursable DiGA and DiPA nach §§ 33a, 139e SGB V. Die Prüfung erfolgt dort nicht durch den GKV-Spitzenverband, sondern durch das BfArM im sogenannten Fast-Track-Verfahren, mit eigenen Anforderungen an Sicherheit, Datenschutz und den Nachweis positiver Versorgungseffekte. Bevor Sie einen HMV-Antrag vorbereiten, lohnt sich deshalb die Klärung: Handelt es sich um ein klassisches Hilfsmittel – oder um eine DiGA? Bei Produkten mit Software- und Hardware-Anteil ist im Einzelfall zu prüfen, welcher Weg zutrifft. Sprechen Sie uns bei Unsicherheit gern an.
How the Application Procedure Works
1. Check listability. Before filing an application, a pre-check pays off: does your product match the definition and indications of an existing product type? A mismatched product type is one of the most common reasons applications fail or are significantly delayed. We offer exactly this pre-check as part of an initial document review (Erstdokumentenprüfung).
2. File the application. Applications are submitted via the GKV-Spitzenverband's web portal. The manufacturer itself, or a person authorised in writing on the manufacturer's behalf, is entitled to apply.
3. Application review. If documents are missing, the GKV-Spitzenverband contacts you directly first. Once all documents are complete, the substantive review begins – involving the relevant competence unit or the Medical Service (Medizinischer Dienst) where necessary.
4. Hearing before a possible rejection. Before the GKV-Spitzenverband rejects an application, it gives you a written hearing. This gives you the opportunity to still provide missing evidence and respond. In any case, you'll receive a reasonable deadline to submit outstanding documents.
5. Decision notice (Bescheid). Once the review is complete, the GKV-Spitzenverband issues a decision on whether the product is accepted or the listing is rejected.
6. Appeal (Widerspruch). You can appeal a negative decision within one month of notification.
7. Publication. In the case of a positive decision, the product is published with an assigned position number in the Bundesanzeiger (Federal Gazette) and in the Hilfsmittelverzeichnis after approximately 4 weeks.
The Documents You Need for Your Application
Which evidence you need to submit specifically depends on your product. As a rule, this includes:
- Declaration of conformity
- Image of the product labeling
- Users Manual for use in German
- Order forms and accessory lists
- Product brochure and promotional material
- Details of scope of delivery
- Test evidence, where required
- Evidence of medical benefit, where required
- A product sample, where required
Submitting these documents complete and in the required quality noticeably shortens the review time – every follow-up query from the GKV-Spitzenverband costs additional weeks.
Common Mistakes That Delay or Derail an Application
The same pitfalls come up again and again in practice:
- Wrong product group or product type. The product matches neither the definition nor the indication of the chosen product type. A listing is then unlikely unless the intended purpose and indication scope are adjusted.
- Unusable test evidence. The submitted test evidence refers to the wrong standard, is outdated, or doesn't cover the relevant requirements.
- Insufficient evidence of medical benefit. Especially for novel products, a general product description isn't enough – what's required is the current, scientifically recognised state of knowledge.
- Instructions for use not fully in German. Foreign-language or incompletely translated manuals regularly trigger a request for resubmission.
- Missing evidence from the notified body,where required for your product.
- Expired or expiring conformity evidence. The GKV-Spitzenverband also checks the validity period of submitted certificates. If you're still working with a time-limited MDD certificate due to the MDR transition, clarify this before applying.
- Incomplete order forms or accessory lists without clear item numbers.
- No product sample, or one packaged incorrectly.
- Missed deadlines on follow-up requests. Anyone who doesn't respond in time to a request from the GKV-Spitzenverband risks rejection for lack of evidence.
- Ignoring ongoing updates to the product group. The GKV-Spitzenverband regularly revises product groups – for example definitions, indications, or technical requirements. Basing your application on an outdated version risks corrections or delays.
Why Starting Early Pays Off Now
Every incomplete document further extends the process.If you realistically want your product listed still in 2026, start now with the pre-check and the assembly of your documents – the year is already well underway, and every additional month shortens the time window that remains.
A second reason for urgency: the GKV-Spitzenverband continuously updates individual product groups, adjusting definitions, subgroups, and requirements to reflect medical and technical progress. Checking the current status of your product group therefore belongs in every application preparation – so you avoid building your application on outdated requirements.
We Get Your Product Listed in the Hilfsmittelverzeichnis
Getting listed in the Hilfsmittelverzeichnis is a regulatory procedure with plenty of detail – from correct product classification to complete evidence. BEO BERLIN has guided medical aid manufacturers through exactly this process for many years. Our services include, among others:
- The assessment of your product’s eligibility for listing of your product, including classification under the right product group and product type,
- The compilation and pre-review of your application documentsso follow-up queries from the GKV-Spitzenverband are avoided from the start,
- The filing of the application as your authorised representative and handling ongoing communication with the GKV-Spitzenverband,
- The support during hearings and appeal proceedings,should follow-up queries or a rejection occur,
- The ongoing market monitoring,so you stay informed about updates to your product group.
Start Now to Still Qualify for Listing in 2026
Getting listed in the Hilfsmittelverzeichnis is worthwhile – but it isn't a process you can wrap up in a few days. Correct product classification, complete documentation, and a close eye on ongoing updates determine how quickly and reliably your application succeeds.
Want your product listed in the Hilfsmittelverzeichnis still this year? Contact us – we'll check listability together with you and guide you through the entire application process.
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